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Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia

Status

Unknown status

Phase

Phase 4

Locations

Ukraine

Study Type

Interventional

Intervention

Fenofibrate

Simvastatin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Simvastatin, Fenofibrate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 Diabetes Mellitus
Fasting triglycerides ≥ 1,7 mmol/l
Acute coronary syndrome at least before 5 and maximum 21 days before the inclusion
If previously treated with statin therapy, the dose should be equivalent to 40 mg of simvastatin at inclusion
In case of previous statin therapy, last LDL-C measurement before event should be ≤ 2,6 mmol/l
Written informed consent obtained

Exclusion Criteria:

Heart failure IV class (NYHA)
Acute decompensated heart failure
Life expectancy no more than 1 year
Chronic kidney disease (CKD) with Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
Severe chronic liver diseases with Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 Upper Limit of Normal (ULN)
Known gallbladder disease, including cholecystolithiasis
Creatinphosphokinase (CPK) > 5 ULN at baseline
Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia
Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,
Known allergy to peanut or arachis oil or soya lecithin or related products
Hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs
Concomitant administration of potent cytochrome P450 isoenzyme 3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone)
Pregnancy and lactation

Sites / Locations

State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simvastatin and Fenofibrate

Simvastatin

Arm Description

Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)

Simvastatin 40 mg once daily orally for 52 weeks (1 year)

Outcomes

Primary Outcome Measures

Percentage change from baseline in triglycerides (TG) at week 12

Secondary Outcome Measures

Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12

Percentage changes from baseline in apoB/apoA1 ratio at week 12

Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12

Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12

Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12

Percentage changes from baseline in uric acid at week 12

Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52

Percentage changes from baseline in apoB/apoA1 ratio at week 52

Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52

Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52

Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52

Percentage changes from baseline in uric acid at week 52

Full Information

NCT ID

NCT02015988

First Posted

December 14, 2013

Last Updated

August 3, 2016

Sponsor

Koval' O., MD

1. Study Identification

Unique Protocol Identification Number

NCT02015988

Brief Title

Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

Official Title

Effectiveness and Tolerability of Early Initiation of Combined Lipid -Lowering Therapy Included Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus, Hypertriglyceridemia and Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Koval' O., MD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.

Detailed Description

The primary objective of this parallel group study is to demonstrate that the combined therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin based on the comparisons of change of TG levels after 12 weeks of treatment compared to baseline. Secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the European Society of Cardiology 2011 (ESC 2011) non-HDL-C target (less than 2,6 mmol/l), change of apolipoprotein B/apolipoprotein A1 (apoB/apoA1) ratio, High-Density Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C) and Uric Acid (UA) after 12 weeks and 52 weeks (1 year) of treatment compared to baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia

Keywords

Acute coronary syndrome, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Simvastatin, Fenofibrate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin and Fenofibrate

Arm Type

Experimental

Arm Description

Simvastatin 40 mg once daily and fenofibrate 145 mg once daily orally for 52 weeks (1 year)

Arm Title

Simvastatin

Arm Type

Active Comparator

Arm Description

Simvastatin 40 mg once daily orally for 52 weeks (1 year)

Intervention Type

Drug

Intervention Name(s)

Fenofibrate

Other Intervention Name(s)

Tricor

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Other Intervention Name(s)

Zocor-forte

Primary Outcome Measure Information:

Title

Percentage change from baseline in triglycerides (TG) at week 12

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 12

Time Frame

Week 12

Title

Percentage changes from baseline in apoB/apoA1 ratio at week 12

Time Frame

Baseline, Week 12

Title

Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 12

Time Frame

Baseline, Week 12

Title

Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 12

Time Frame

Baseline, Week 12

Title

Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 12

Time Frame

Baseline, Week 12

Title

Percentage changes from baseline in uric acid at week 12

Time Frame

Baseline, Week 12

Title

Percentage of patients who achieved non-High-Density Lipoprotein-Cholesterol (non-HDL-C) level less than 2,6 mmol/l at week 52

Time Frame

Week 52

Title

Percentage changes from baseline in apoB/apoA1 ratio at week 52

Time Frame

Baseline, Week 52

Title

Percentage changes from baseline in non-High-Density Lipoprotein-Cholesterol (non-HDL-C) at week 52

Time Frame

Baseline, Week 52

Title

Percentage changes from baseline in High-Density Lipoprotein-Cholesterol (HDL-C) at week 52

Time Frame

Baseline, Week 52

Title

Percentage changes from baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) at week 52

Time Frame

Baseline, Week 52

Title

Percentage changes from baseline in uric acid at week 52

Time Frame

Baseline, Week 52

Other Pre-specified Outcome Measures:

Title

Number of adverse events (AE) caused discontinuations of investigational products

Time Frame

Up to 52 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 Diabetes Mellitus Fasting triglycerides ≥ 1,7 mmol/l Acute coronary syndrome at least before 5 and maximum 21 days before the inclusion If previously treated with statin therapy, the dose should be equivalent to 40 mg of simvastatin at inclusion In case of previous statin therapy, last LDL-C measurement before event should be ≤ 2,6 mmol/l Written informed consent obtained Exclusion Criteria: Heart failure IV class (NYHA) Acute decompensated heart failure Life expectancy no more than 1 year Chronic kidney disease (CKD) with Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 Severe chronic liver diseases with Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 Upper Limit of Normal (ULN) Known gallbladder disease, including cholecystolithiasis Creatinphosphokinase (CPK) > 5 ULN at baseline Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, Known allergy to peanut or arachis oil or soya lecithin or related products Hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs Concomitant administration of potent cytochrome P450 isoenzyme 3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone) Pregnancy and lactation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olena A Koval', MD, PhD

Organizational Affiliation

State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"

Official's Role

Principal Investigator

Facility Information:

Facility Name

State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"

City

Dnipropetrovsk

Country

Ukraine

12. IPD Sharing Statement

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Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

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